The Recall Desk
HighFDA (Devices)·Z-0279-2017·Announced 2016-10-26

Windstone Medical Recalls Universal Surgery Kits Due to Sterility Concerns

Windstone Medical Packaging is recalling 99 Universal Pack surgery kits because the included Medtronic gloves may have splits or holes that compromise sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (compromised sterility in surgical kits) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 99 Universal Pack kits (Kit number AMS2036) used for general surgery in hospital operating rooms. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES (Part # 13140) included in the custom kits. The gloves may contain splits or holes that compromise sterility.

The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall involves specific lot numbers and expiration dates, including 63911 (6/1/2014), 61913 (8/10/2014), 71796 (9/3/2014), 68840 (9/12/2014), 58646 (12/17/2014), 74391 (6/18/2016), and 78100 (6/30/2016).

Healthcare facilities should check their inventory for these specific lot numbers and expiration dates. If the affected kits are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
99

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 150 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 150 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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